To investigate the efficacy and adverse effects of mifepristone tablets in widely used conditions, to evaluate the relationship between interests and risks used in general or special populations, to further observe the safety and efficacy of drugs.
Uterine fibroids (also referred to as myomas, leiomyomas, leiomyomata, and fibromyomas) are non-cancerous (benign) tumors that grow within the muscle tissue of the uterus. Approximately 20-40% of women 35 years and older have fibroids. While many women with fibroids do not experience any symptoms, the location and size of fibroids can cause symptoms that can affect a woman's quality of life. Fibroids are hormonally sensitive so symptoms are likely to be cyclical with menstruation. Fibroid growth is dependent on hormone levels; an increase in a woman's hormone levels may cause the size of fibroids to increase. During menopause, these hormones decrease dramatically and may cause fibroid symptoms to diminish. Mifepristone is an antiestrogen hormone that antagonizes progesterone at receptor levels. Estrogen is generally considered to be a major contributor to uterine fibroids, but many studies have confirmed that progesterone can promote fibroid cell mitosis, and thus promote fibroids growth. In recent years, domestic and international clinical studies have shown that mifepristone treatment for 3 months can significantly reduce the size of uterine fibroids to achieve complete amenorrhea, improve bleeding caused by anemia, reduce clinical symptoms, uterine fibroids to reduce the size of complex Of the hysterectomy surgery into a simple, to avoid surgery caused by other organs of the injury, shorten the operation time, reduce the amount of surgical bleeding and blood transfusion, so that patients recover faster after surgery The literature reported the clinical use of 50mg, 25mg, 10mg and 5mg. The minimum dose of 10mg daily, 3 months can reduce the average size of uterine fibroids nearly half. Daily 5mg on fibroids shrink is not obvious. Mifepristone tablets is developed by the China Resources Zizhu Pharmaceutical Co., Ltd. Drugs and Drugs 1.6, each tablet 10mg, for adult age women have moderate to severe symptoms of uterine fibroids before the treatment of national food and drug supervision and management General Administration of the People 's Republic of China on October 24, 2014 approved its listing, the drug registration approval number: 2014S00506. According to the State Food and Drug Administration drug clinical approval requirements of this product need to carry out IV clinical research, the purpose is to examine the efficacy of drugs in a wide range of conditions and adverse reactions to evaluate the general or special population in the use of the interests and risks , To further observe the safety and efficacy of drugs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
434
Daily 10mg, Po, Qd, each 10mg/tablets。Start from 1 to 3 days of the menstruation, take 1 tablet after 2 hours of fasting, and no eating for 2 hours after taking the pill. Group A and group B: treatment for 12 weeks, Group C: treatment for 24 weeks.
Security assessments
Security assessments will include monitoring and recording all adverse events (AEs) and serious adverse events (SAEs).
Time frame: Up to study completion at approximately 24 weeks
Changes of uterine fibroids(maximal fibroids)
Comparison of changes in the volume group of uterine fibroids (maximal fibroids)before and after treatment
Time frame: Through study completion，an average of half year
Comparison of changes in the uterine volume
Comparison of changes in the uterine volume before and after treatment.
Time frame: Through study completion，an average of half year
Comparison of the relevant indicators of anemia
Before and after treatment on the relevant indicators of anemia(red blood cell count, erythrocyte ratio, hemoglobin) groups of visits to the relative baseline changes in the value of the description, the group comparison.
Time frame: Through study completion，an average of half year
Evaluation of the uterine bleeding symptoms
The uterine bleeding symptoms were recorded before treatment.
Time frame: Through study completion，an average of three months
Operation situation(Perioperative transfusion improvement,Type of surgery)
When surgery was occurred, recording perioperative blood transfusion values; if the operation was performed, the proportion of subjects using minimally invasive surgery was calculated for all subjects.
Time frame: Through study completion，an average of half year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing Maternal and Child Health Care Hospiatl of Capital Medical Hospital
Beijing, Beijing Municipality, China
Beijing University First Hospital
Beijing, Beijing Municipality, China
Fuling Center Hospital of Chongqing City
Chongqing, Chongqing Municipality, China
The Second Hospital of Chongqing Medical Universit
Chongqing, Chongqing Municipality, China
The Second Hospital of Logyan
Longyan, Fujian, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Guangdong Hospital for Maternal amd Child Health Care
Guangdong, Guandong, China
The Third Affillated Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Fouth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical Universty
Harbin, Heilongjiang, China
...and 16 more locations
Clinical symptom scores
The clinical symptom scores were recorded before treatment.
Time frame: Through study completion，an average of half year